The following description in this Background section includes information that may be useful in understanding the present invention. It is not an admission that any such information is prior art, or relevant, to the presently claimed inventions, or that any publication specifically or implicitly referenced is prior art.
Safe patient handling, care and maintenance have been the penultimate focus in hospital and operating room environments for decades. In such focus the desire to maintain a truly sterile environment during surgical procedures in the operating room has led to a long lasting paradigm of directing attention for sterility to that of the patient him/herself. Thus, prior systems for creating sterility have related to using sterile drapes for covering the patient, in whole or in part, leaving only the body area to be treated exposed to the surgeon's hands and utensils.
The prior art is replete with patient draping systems. For example, U.S. Pat. No. 4,119,093 to Goodman discloses a drape system for covering a patient's limb while also covering adjoining patient torso and surrounding area. U.S. Pat. No. 3,930,497 to Krebs et al discloses a patient body drape that allows exposure of limbs. U.S. Pat. No. 6,725,864 to Ewonce et al discloses a patient drape for covering the patient's shoulder. In another example, U.S. Pat. No. 4,169,472 to Morris discloses a patient drape that also includes fluid collecting capability. U.S. Pat. No. 4,945,924 and U.S. Pat. RE35,427 to Poettgen disclose patient drapes that have an insulation quality. U.S. Pat. No. 4,334,529 to Wirth discloses a patient drape equipped with holes for channeling cables from a nonsterile equipment side to a sterile surgery side. In U.S. Pat. No. 5,010,899 to Thompson, a patient drape is disclosed that includes loops for directing surgical equipment, such as tubes and wires. U.S. Pat. Nos. 6,055,987 and 6,216,700 to Griesbach disclose a patient drape with hook and loop type fasteners. In U.S. Pat. Nos. 5,341,821, and 5,454,381 to DeHart, a patient drape is disclosed wherein the drape has transparent sections to assist the surgeon viewing while in U.S. Pat. No. 6,612,310 to Sklar a patient drape is disclosed with a window for viewing non-sterile equipment such as monitors close to the actual surgical site. Other drape systems have sought to cover the patient in a canopy such as disclosed in U.S. Pat. No. 6,367,476 to Conn but such a system is still patient drape based.
While sterile patient drapes as noted above have proven useful in their myriad forms, they predominantly focus on draping the patient and surrounding adjacent areas of the operating theater, as opposed to surgical equipment alone for the sake of creating a sterile environment about the equipment. Thus, there is a need for inventions to address creating a sterile environment about non-sterile operating room equipment.
Some drape systems have sought to cover a limited type of operating room fixtures such as the operating table itself as disclosed in U.S. Pat. No. 5,875,780 to Rodriguez, U.S. Pat. No. 4,164,941 to Knapick et al and U.S. Pat. No. 7,604,007 to Wooley, but operating tables comprise fixtures that are indelibly tied to a surgical area of operation providing sterile working space for the doctors to place surgical equipment close to their proximity.
With the increasing advent of hospital or care facility born infections, commonly referred to as “hospital associated infections” or HAis, there has been an increased awareness for the need for sterilizing equipment within an operating room. It is well known that operating rooms and other areas in hospitals should be sterile in order to prevent hospital acquired infections. Despite this knowledge, hospital acquired infections are a significant problem in the healthcare system. It has been estimated that 5% of all hospitalizations in the U.S. are associated with a hospital-acquired infection. Additionally, the CDC in 2009 estimated that the direct cost of hospital associated infections for U.S. hospitals was in the range of $29-$45 billion dollars. The current procedure for sterilization of powered equipment, according to the Association of Perioperative Registered Nurses mainly involves, among other things, wiping down the equipment with manufacturer-recommended detergent/germicide and then drying the equipment with a lint free cloth. Common methods of sterilization used in hospitals for cleansing non-electronic instruments include sterilization with steam/autoclave systems, chemicals such as bleach and peroxide, dry heat, and ethylene oxide gas. Radiation methods such as gamma ray exposure, electron beam processing, X-rays, and ultraviolet rays can also be used to sterilize medical equipment.
Although manual sterilization techniques for heavy equipment as noted above are available, their application is highly problematic and time consuming. In some sterilization methods, the equipment would have to be taken to a special area for such as electron beam or gamma ray exposure, or the beam and ray sources would have to be transported to the operating room. The same would be true for ethylene oxide gas, X-rays and UV radiation wherein the entire operating room containing the equipment would have to be exposed. Given the impracticality of constantly re-sterilizing operating room equipment manually before each surgery, a solution is recognized to use sterile draping for equipment. For example, clear and opaque drapes have been designed to covering a C-Arm fluoroscopes which are used in surgery. Other drapes include clear plastic for covering X-ray cassettes and X-ray intensifiers, microscopes, and hand held electronic modules for controlling large equipment. There are also drapes for such as a cart for supporting a C-arm imaging system, a drape for a medical cart, see U.S. Pat. No. 6,497,233 to DeAngelis, which is merely a rectangular sheet, a drape for a pivoting arm for supporting a limb such as disclosed in pivot arm U.S. Pat. No. 6,629,944 to Smart, and systems for securing drapes to medical equipment such as U.S. Pat. No. 7,775,213 to Henke-Sarmento et al, and large dimensioned general purpose drapes for covering OR equipment such as U.S. Patent application 2006/0150987 to Dillon et al.
Although the above equipment draping concepts have been disclosed, none of them apply to the specific concerns regarding patient handling equipment such as patient hoists, lifts and the like. Rather, much of the equipment drape systems merely comprise sheets of material that can be used to wrap around operating room equipment but cannot easily accommodate support structures built into patient lifting devices.
Concerning safe patient handling issues as it relates to sterility and the sterile environment of the operating room, often times there is a need to manipulate and position a patient while in the operating room before surgery, during surgery, and/or after surgery, all under sterile conditions. Patients are hung in a gurney or otherwise in a sling, for example, a limb is propped up or supported in a sling by a hoist, and the patient positioned for surgery and draped. If the patient's body or limb must be repositioned, the sterile draping is disturbed by the need to manipulate the patient against the non-sterile sling. Further, presently doctors and operating room staff must themselves physically lift, hold, and rotate patients and/or patient body parts, such as arms and legs, all of which weigh substantial poundage. Such patient body manipulation is often problematic in numerous ways with respect to safe patient handling including danger to patient from accidentally being dropped, and subsequent loss of sterile environment due to a patient drape, or part thereof, touching non-sterile and non-prepped slings or other operating room equipment. Under such conditions, not only is the patient at risk of mishandling, the operating room staff is also at risk in the form of body injury from lifting and supporting patient body and body part weight and often at angles unfit for maintenance of good back muscle health. Thus, a focus on draping the patient as opposed to draping operating room patient handling equipment has set up work environment conditions that can result in occupational injuries to hospital operating room staff.
For example, according to the Bureau of Labor and Statistics, nurses' aides, orderlies, and attendants had 44,930 days away from work due to injury in 2007. Their injury rate was 465 cases per 10,000 workers. These figures are higher than for construction workers who had 34,180 days away from work and an injury rate of 394 cases per 10,000 workers. Further, the musculoskeletal disorder rate of the healthcare workers cited above (252 casesper 10,000 workers) was more than seven times the average national rate for all occupations. (American Nurse Today; July 2010, Vol. 5. No. 7, Patient handling: Fact vs. Fiction, Ninica L. Howard M S, CPE.) Other studies have shown that institution of safe patient handling techniques which comprise use of lifting devices not only saved institutions large sums of money, they have actually recaptured the costs of using such equipment by the savings on workers compensation for injuries caused by lifting patients by hand. (Spiegel, Jerry, Analee Yassi, Lisa Ronald, Robert Tate, Penny Hacking, Teresa Colby, “Implementing a resident lifting system in an extended care hospital: Demonstrating Cost-Benefit,” AAOHN Journal, March 2002, 50(3). Nelson, Audrey, Mary Matz, Fangfei Chen, Kris Siddharthan, John Lloyd, Guy Fragala, “Development and evaluation of a multifaceted ergonomics program to prevent injuries associated with patient handling tasks,” International Journal of Nursing Studies, August 2006, 43(6). Collins, J. W., L. Wolf, J. Bell, B. Evanoff “An evaluation of a′best practices' musculoskeletal injury prevention program in nursing homes,” Injury Prevention, 2004, 10. National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention, Department of Health and Human Services, Safe Lifting and Movement of Nursing Home Residents, February 2006.) Thus, there is a need to create inventions that will lower the number of healthcare worker injuries caused by heavy lifting and to provide for placement of otherwise unsterilizable equipment in the operating room under sterile conditions.
Surgical slings for lifting or supporting a patient are similar to the surgical drape in that prior sling devices were not typically made sterile in and of themselves. Rather, sterile drape material was used between the lifting/support sling and the patient if a lifting device is used at all. U.S. Pat. Nos. 4,702,465 and 4,848,363 to McConnell, for example, discloses a telescoping sterile upright support assembly wherein a lifting/support apparatus is not sterilized and not draped but nonetheless described for use within the sterile field in the operating room. The apparatus is designed to hang into the sterile field thus allowing its easy entry and exit from the surgery area. Thus, certain devices for lifting patient body parts have been disclosed for uses within a sterile environment, but there is no conception disclosed for a sterile patient body support sling and/or hoist system designed for use in patient handling within the sterile environment. Moreover, the present hoisting system components such as crossbars to which slings are attached are lacking in design in that due to sling hanging points manufactured at the ends of the bar, and the methodology and need to attach sling loops at those limited locations, causes the sling to bunch up and in turn cause undesired pressure and compression on patient body parts.
As will be disclosed below, notwithstanding the numerous prior surgical drape configurations, there remains a long felt need in the art of safe patient handling, particularly in sterile operating room environments, for drape systems, slings and improved lifting device components such as crossbars that will provide the ability to use, within the operating room and under sterile conditions, bulky equipment and machinery, such as patient body lifting and support cranes, jacks, and hoists and the like, and the lifting slings and crossbars that function with the lifting devices.